Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea
KGDobesity
Evaluation of Efficacy and Safety of Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea.
1 other identifier
interventional
150
1 country
1
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea (OSA) in patients with obesity and Type 2 DM and in patients with obesity and/or OSA. This will be a randomized, open-label three arm controlled study comparing weight loss in obese participants with type 2 diabetes and/or obstructive sleep apnea treated for 9 months with 3:1 \[fat\]:\[protein+carbohydrate\] ratio, 1600 kcal/day diet (Group A) with weight loss in participants treated with orlistat 120 mg TID and lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group B), and in participants treated with only lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group C).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 obesity
Started Jan 2014
Longer than P75 for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedFirst Posted
Study publicly available on registry
February 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedAugust 17, 2018
August 1, 2018
6.6 years
July 19, 2013
August 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of body mass index from baseline in 9 months period
The change of weight and the BMI(body mass index) will be calculated.
9 months
Secondary Outcomes (3)
Change from baseline in glucose blood level in patients with diabetes mellitus in 9 months.
9 months
Change of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity
9 months
To evaluate safety of ketogenic diet as a treatment of obesity.
9 months
Study Arms (3)
Ketogenic diet, lifestyle counseling
ACTIVE COMPARATORketogenic diet consisted of 3:1\[fat\]:\[protein+carbohydrate\] weight ratio with 1600kcal restriction.
Orlistat, Lifestyle counseling
ACTIVE COMPARATOROrlistat 120 mg TID, standardized diet and lifestyle-modification counseling based on the LEARN (Life, Exercise, Attitudes, Relationships,and Nutrition) program with recommended caloric goal of 1600 kcal/day.
Standartized diet, Lifestyle counseling
ACTIVE COMPARATORStandardized diet and lifestyle-modification counseling based on the LEARN (Lifestyle, Exercise, Attitudes, Relationship, Nutrition) program with recommended caloric goal of 1600kcal/day.
Interventions
ketogenic diet will consist of 3:1\[fat\]:\[protein+carbohydrate\]weight ratio with 1600 kcal restriction. Diet will last 9 months.
Orlistat 120 mg TID for 9 months; life style intervention with recommended caloric goal of 1600 kcal/day.
Standardized diet treatment for 9 months with recommended caloric goal of 1600kcal/day.
Eligibility Criteria
You may qualify if:
- age 18-70
- ability and willingness to signed informed consent form
- BMI more than 30kg/m2, with type 2 DM and/or OSA
- For diabetic participants, stable hypoglycemic medications for at least 2 months
- For participants with OSA, previously documented polysomnogram with apnea/hypopnea index (AHI)\>15/h.
You may not qualify if:
- BMI change of +/- 3.0 kg/m2 of baseline BMI within past 12 months.
- History of bariatric surgery ≤ 3 years prior to enrollment.
- Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, and active systemic cancer.
- History of uncontrolled hyperlipidemia
- For participants with DM, change in the dose or type of hypoglycemic treatment within 2 months prior to enrollment.
- Psychosis within six months of enrollment, evidenced by treatment with anti-psychotic medications with recent medication initiation or dose increase.
- Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
- History of hyperthyroidism
- History of glaucoma
- History of cerebrovascular disease or unstable heart disease within 6 months of enrollment
- Pregnancy
- Use of any investigational drugs within 3 months of enrollment.
- Inability or unwillingness of subject to give written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mid-Atlantic Epilepsy and Sleep Center, LLC
Bethesda, Maryland, 20817, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pavel Klein, M.D.
Mid-Atlantic Epilepsy and Sleep center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 19, 2013
First Posted
February 24, 2014
Study Start
January 1, 2014
Primary Completion
August 1, 2020
Study Completion
September 1, 2020
Last Updated
August 17, 2018
Record last verified: 2018-08